Location
Stevenage, Hertfordshire | United Kingdom
Job description
Achilles is a fast paced, trail blazing bio-technology company focussed on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer company. Originating from pioneering research at Cancer Research UK (CRUK), the Francis Crick Institute and University College London (UCL), we use DNA sequencing data from each patient, together with our proprietary PELEUS™ bioinformatics platform, to identify clonal neoantigens specific to that patient. From this, we develop personalised T cell therapies and currently have two programmes in the clinic for the treatment of Lung Cancer and Metastatic Malignant Melanoma.
As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy making sense of ambiguity and thrive on making things happen even when there is not a detailed brief.
Role Summary:
We are seeking a Senior Associate to primarily perform and support QA duties at a manufacturing site for Achilles product (Investigational Medicinal Product), thereby ensuring GxP and other regulatory requirements relating to clinical trial manufacture are met and maintained. The role will also support the separate Achilles Quality Management System, ensuring activities conform to regulatory requirements.
Responsibilities:
- Support the Creation, Maintenance and Continuous Improvement of Achilles Quality Management System (QMS) Ensuring Compliance with Regulatory Requirements
- Perform Operational QA Duties to Ensure GxP Compliance and Regulatory Requirements Relating to the Manufacturing and Conduct of Clinical Trials
- Support the Administration of the Company’s Document Management System
- Perform QA Review and Approval of Procedures, Master Batch Records, and any Other Relevant cGMP Documentation
- Perform Batch Documentation Review Activities
- Review Standard Operating Procedures (SOPs) to Ensure Compliance with GMP and Other Relevant Regulatory Requirements
- Review and Approval of Change Controls
- Work with teams across the business and externally to maintain compliance with both Achilles QMS and Catapult’s QMS in a multi-tenant manufacturing facility
- Support Operational Functions with Review and Approval of Deviation Investigations, Ensuring Effective Root Cause Analysis
- Ensure that Deviations, CAPAs, Protocols/Reports and Other Applicable Documents are Approved Within the Designated Timelines.
- Review and Approve Out of Specification Investigations
- Work with Teams Across the Business and Externally to Investigate Quality Issues
- Issue and Review Corrective and Preventative Actions (CA/PAs)
- Support Complaints Management Process and Where Appropriate Respond to Complaint Investigations
- Support with Any Qualification & Validation Activities
- Provide Advice and Guidance to the Wider Team with Support from the QA Manager
- Perform Internal Audits to Determine Compliance with GMP and Identify Areas for Improvement
- Perform External Audits as Necessary
- Support the QA Manager with Hosting Customer Audits and Regulatory Inspections
- Support Senior Management with the Co-ordination of Recall Activities
- Support of Provision of In-house Training Activities
- Provide Support and Data for Achilles Quality Management Reviews
Requirements
Essential:
- Experience working in QA in a Biotech/Biologics/ATMP GMP Environment - Ideally on MIA /MIA IMP Licensed Site
- Technical Knowledge of Aseptic Manufacturing Processes, Sterility Assurance and Laboratory Techniques
- Thorough Understanding of EU and US GMP Requirements
- Experience within a GMP Quality Assurance Department
- Experience Investigating Deviations, Complaints, Reviewing Change Controls, Implementing CAPAs and Conducting Internal Audits
- Experience with Batch and Associated Documentation and its Review
Desirable:
- Understanding of Clinical Trial Directives/Regulations
- Knowledge about Regulatory Requirements for ATIMPs
- Experience with Environmental Monitoring
- Experiences with Clean Rooms
- Experience in a QC GMP Environment
- Experience with Equipment Qualification Activities
- Experience with Validation Plans, Activities and Reports
- Experience of Working with Sponsors, Contract Manufacturing Organisations and Contract Testing Laboratories
- Experience with Document Preparation/Review in Support of Regulatory Submission Packages
- Experience Conducting External Audits
- Knowledge on HTA Requirements for Cells and Tissues
Benefits
This is a permanent role, offering a competitive benefits package
At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot
Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.
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